Status:
RECRUITING
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Sensation Disorders
Sensation, Phantom
Eligibility:
All Genders
18+ years
Brief Summary
During breast surgery, sensory nerves are cut which may lead to reduced sensation and pain. Surgical reinnervation techniques have been developed with the aim of improving postoperative sensation by p...
Detailed Description
SIGNIFICANCE During removal of breast tissue that is required for mastectomy procedures, the nerves that supply the breast skin and the nipple areola complex (NAC) are sacrificed. This results in fai...
Eligibility Criteria
Inclusion
- Age over 18
- Patient is scheduled for gender mastectomy surgery (including nipple sparing mastectomy and mastectomy with free nipple graft) or NSM with breast implant or autologous reconstruction
- Patient is capable and willing to provide informed consent
Exclusion
- Patient has a nerve condition that does not allow for assessment of sensation
- Any subject who at the discretion of the Investigator is not suitable for inclusion in the study or is unlikely to comply with follow-up schedule
- Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy
- Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized)
Key Trial Info
Start Date :
February 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2033
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06094257
Start Date
February 9 2022
End Date
March 1 2033
Last Update
August 27 2025
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Weill Cornell Medicine
New York, New York, United States, 10065